Configurable control handle for catheters and other surgical tool

ABSTRACT

A control handle for a surgical tool, e.g., an irrigated ablation catheter for use with a fluid side arm, has a housing defining an interior cavity and having a port through which the component can extend into the interior cavity. The housing has a detachable plug covering at least a portion of the port and being at least partially surrounded by a recessed groove to facilitate detachment of the plug from the housing. The recessed groove may be formed on an outer surface of the housing and there may be a second recessed groove on an inner surface of the housing generally tracing the first groove. The plug may also include a hinge to allow the plug to be arranged at an angled position relative to the housing without being fully detached from the housing.

CROSS-REFERENCE TO COPENDING APPLICATION

The present application is a Continuation under 35 U.S.C. § 120 of U.S.patent application Ser. No. 13/902,639, filed May 24, 2013. The entirecontents of this application is incorporated by reference herein intheir entirety.

FIELD OF INVENTION

This invention relates to a control handle, in particular, a controlhandle for a medical device, including a catheter.

BACKGROUND

Electrode catheters have been in common use in medical practice for manyyears. They are used to stimulate and map electrical activity in theheart and to ablate sites of aberrant electrical activity. Depending onthe procedure, the catheter may be used with or without irrigation, thatis, with or without fluid, e.g., saline, delivered to a distal sectionof the catheter to irrigate a tissue target site. Where irrigation isdesired, a conventional control handle of a catheter may be used with aside arm connected to a luer hub in fluid communication with a fluidsource, where the side arm extends into the control handle. To that end,housing of the control handle has an opening or hole for the side arm.Where irrigation is not desired, the housing of a suitable controlhandle may be identical except for the hole. But, despite the closestructural similarity of these two types of control handles, two sets ofcapital tool molds are needed in the manufacture of these handles, witheach type requiring independent qualifications and stocking ofinventory. The requirement for separate parts places additional burdenon the supply chain because both configurations are kept as safety stockas insurance against marketing forecast revisions.

Using handle housings with uncovered holes for constructing eithernonirrigated and irrigated catheters is possible but there areshortcomings. Functionally, an uncovered hole can increase the risk ofcontamination, damage and/or failure of electronics and componentsinternal the control handle. Aesthetically, an uncovered hole presentsan undesirable appearance of an unfinished or damaged product.

Accordingly, there is a desire for a medical device control handle thatcan be assembled and configured for multiple uses, including irrigatedand nonirrigated catheter-based procedures. A configurable handle wouldallow a single part number to serve multiple roles and would requireconfiguration only at the time of assembly, thereby reducing part numberproliferation and inventory carrying costs.

SUMMARY OF THE INVENTION

The present invention is directed to a control handle for a medical orsurgical tool configurable for use selectively with or without acomponent. In one embodiment, the control handle has a housing definingan interior cavity and having a port through which the component canextend into the interior cavity. In accordance with a feature of thepresent invention, the housing has a detachable plug covering at least aportion of the port and being at least partially surrounded by arecessed groove to facilitate detachment of the plug from the housing.The recessed groove may be formed on an outer surface of the housing andthere may be a second recessed groove on an inner surface of the housinggenerally tracing the first groove. The plug may also include a hinge toallow the plug to be oriented at an angled position relative to thehousing without being fully detached from the housing. In a moredetailed embodiment, the surgical tool comprises an irrigated ablationcatheter and the component comprises a fluid side arm.

In another embodiment, the control handle is for a catheter adapted foruse with an irrigation side arm. The control handle includes a housingdefining an interior cavity and providing a port for the irrigation sidearm and a detachable plug covering the port.

In another embodiment, the control handle includes a housing, areceptacle and a port. The housing has a proximal housing opening incommunication with an interior cavity. The receptacle is inserted intothe interior cavity via the proximal housing opening and has a proximalend with a peripheral flange that merges with a surrounding edge of theproximal opening of the control handle housing. The port overlaps thesurrounding edge of the control handle and the peripheral flange of thereceptacle so that it extends partially on one side into the surroundingedge and partially on the other side into the peripheral flange. Theport is covered by a detachable plug formed in the handle housing andmay include a main portion and a finger extending at an angle from themain portion.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features and advantages of the present invention will bebetter understood by reference to the following detailed descriptionwhen considered in conjunction with the accompanying drawings. It isunderstood that selected structures and features have not been shown incertain drawings so as to provide better viewing of the remainingstructures and features.

FIG. 1 is a perspective view of a control handle in accordance with anembodiment of the present invention.

FIG. 2 is an exploded, partial side cross-sectional view of the controlhandle of FIG. 1 .

FIG. 3 is a detailed exploded perspective view of a distal end of thecontrol handle of FIG. 1 .

FIG. 3A is a cross-sectional view of the control handle of FIG. 3 ,taken along line A-A.

FIG. 4 is a perspective view of a receptacle with a circuit board, andan electrical connector, in accordance with one embodiment of thepresent invention.

FIG. 5 is a perspective view of a control handle with a covered proximalport and additional distal ports, in accordance with another embodimentof the present invention.

FIG. 6 is a perspective view of the control handle of FIG. 5 , with theproximal port uncovered.

DETAILED DESCRIPTION OF THE INVENTION

Referring to FIG. 1 , the present invention is directed to a controlhandle 16 for assembly and use with a catheter 10 or other medicaldevices and surgical tool handles, wherein housing (or a portionthereof) is configurable to provide one or more openings allowing thecontrol handle to be adapted for different uses and applications. In theillustrated embodiment of FIG. 1 , a control handle 16 comprises anelongated housing with two generally similar halves 20 and 22 that areaffixed, e.g., by sonic welding, laser welding, adhesives and/or thelike, to each other along a longitudinal seam 12.

The control handle is configured for one-handed operation. The handlehas a proximal portion 16P, a mid portion 16M and a distal portion 16Dbetween a distal end 30 and a proximal end 32. The proximal portion 16Pis configured with a textured, friction-inducing surface 18 to begripped by the user's hand. The mid-portion 16M has a deflection knob 24on the housing half 22 for controlling deflection of a catheter distaltip section and a tension knob 26 on the housing half 20 for adjustingtension of the deflection knob. The distal portion 16D has a taperedprofile leading to a catheter shaft 17 that extends distally from thedistal end 30 of the control handle 16.

As shown in FIG. 2 , the housing defines an interior cavity 34 betweenthe housing half 20 and the housing half 22 (not shown). As shown inFIGS. 2 and 4 , components housed in or near mid-portion 16M of thecontrol handle include puller wires 35, anchoring members 36 forproximal ends of the puller wires, and a deflection assembly 37responsive to the deflection knob 24. Components housed in or near theproximal-portion 16P of the control handle include a first electricalconnector 38 and a circuit board 40 connected thereto by connector leads42. The circuit board 40 performs function(s) including amplifyingsignals received from electromagnetic sensor(s) (not shown) carried onthe catheter distal tip section, and transmitting them to a computer ina form understandable by a computer (not shown). The circuit board 40may also contain an EPROM chip which shuts down the circuit board afterthe catheter has been used. This prevents the catheter, or at least theelectromagnetic sensors, from being used twice. Also connected to thefirst electrical connector 38 are proximal ends of electrode lead wires44 extending into the control handle 16 from the distal end 30. Distalends of the wires 44 are connected to tip and/or ring electrodes (notshown) mounted on the distal tip section of the catheter.

As shown in FIG. 2 , the distal end 30 of the control handle has anopening 45 through which the catheter shaft 17 extends. Extendingthrough the shaft 17 are components, including electrode lead wires 44,the puller wires 35, electromagnetic position sensor cable andirrigation tubing. With reference to FIGS. 3 and 4 , the proximal end 32of the control handle has an opening 46 configured to receive areceptacle 50 that facilitates coupling of an electrical umbilical cord52 with a second electrical connector 39 adapted for connection to thefirst electrical connector 38 housed in the control handle 16. In theillustrated embodiment, the first electrical connector 38 is a maleconnector with pins 43 positioned at a distal end of the receptacle 50and the second electrical connector 39 is a female socket, although itis understood that the connector structures may be reversed. Theelectrical umbilical cord 52 connects the catheter 10 to a patientinterface unit (not shown) which communicates with an electroanatomicalnavigation system (not shown), e.g., CARTO available from BiosenseWebster of Irwindale, Calif., which is a 3-D mapping system thatprovides electrophysiologists with magnetic location technology andvisualization data of catheter tip and curve location, anatomicalmapping with rapid creation of high-resolution, CT-like maps. Thepatient interface unit functions as a central connection between theelectroanatomical navigation system and the catheter 10.

As shown in FIGS. 3 and 4 , the receptacle 50 has a body defining adistal cavity portion 58, and a proximal opening 59 through which thesecond electrical connector 39 is inserted and received in the distalcavity portion 58. A distal end surface 60 of the receptacle 50 has aplurality of openings 61 through which electrical leads 42 are connectedto pins 43 extending proximally within the cavity portion 58 forconnection with the second electrical connector 39. The proximal opening59 of the receptacle 50 has a surrounding flange 63 which is adapted togenerally seal the proximal opening 46 of the control handle when thereceptacle 50 (along with the second electrical connector 39) isinserted into the proximal opening 46 (FIG. 5 ). To that end, alignmentformations are formed in or on the receptacle 50 to ensure theelectrical connector 39 is “keyed” and inserted into the receptacle 50with the correct alignment and/or orientation. In the illustratedembodiment, asymmetrical slots 66 a and 66 b of different lengths areprovided in side walls 65 a and 65 b, respectively, that match andcorrespond, respectively, with asymmetrical ridges 67 a and 67 b formedon opposite outer surfaces of the electrical connector 39. As shown inFIG. 2 , a sleeve shield 71 may be provided outside of the receptacle 50in surrounding relationship therewith to shield the circuit board 40.The shield may be made of any suitable material, for example, Mu-metal,a range of nickel-iron alloys that are notable for their high magneticpermeability, composed of approximately 77% nickel, 16% iron, 5% copperand 2% chromium or molybdenum. The high permeability makes Mu-metaluseful for shielding against static or low-frequency magnetic fields. Tolock the receptacle 50 in the control handle 16, a flexible flanged tab77 is provided extending distally from a distal surface of theperipheral flange 63, which engages a ridge formation provided on aninner surface of the housing half 22.

Where the catheter 10 is assembled for irrigated procedures, the controlhandle housing 16 is configurable to provide a closely-conforming port68, as better shown in FIGS. 1 and 5 , to allow an irrigation side arm69 to extend into the interior cavity of the control handle. As shown inFIG. 6 , the port 68 is formed on one side in one part by a recessedformation 70 in the peripheral flange 63 of the receptacle 50, and onthe opposite side in another part by a recessed formation 71 in theproximal end 32 of the housing half 20 at the periphery of the proximalopening 46, when the receptacle 50 is received in the handle housing.

In accordance with a feature of the present invention, the controlhandle housing 20 is configurable to provide a covered port 68 where thecatheter 10 is assembled for nonirrigated procedures or procedures thatdo not require an accessory component extending into the control handle.As shown in FIGS. 3 and 5 , the control handle housing presents agenerally closed proximal end with an aesthetically complete appearanceby means of a pre-defined section or detachable “plug” 68P of the handlehousing that can be selectively removed or retained during assembly ofthe control handle.

With reference to FIGS. 3 and 3A, the plug 68P has a defined peripheralboundary in the form of a recessed groove 72 that extends around theplug 68P on an outer surface 41 of the handle housing half 20. In theillustrated embodiment of FIG. 3 , the defined peripheral boundary orgroove 72 surrounds a portion of the plug 68P, for example, about 180degrees, although it is understood that a defined peripheral boundarymay surround a plug in varying degrees, ranging between about 0 to 360degrees, depending on the location and/or configuration of the plug andthe control handle. For example, the defined peripheral boundary maycompletely surround (by 360 degrees) a plug 168P or plug 368P and belocated more distally in/on the control handle housing half 20 or 22, asshown in FIG. 5 . It is understood that the plug may be located anywhereon the housing and assume any shape, e.g., circular, oval, rectangular,polygonal and/or irregular, as appropriate or needed. As shown in FIG.3A, the groove 72 has a thickness t less than the thickness T of thesurrounding housing so that the plug can be readily knocked out, punchedout, broken off or otherwise detached (manually and/or with a tool) andremoved from the handle housing. The groove 72 also provides a visualindication of its location, shape and size. A second matching groove 73(FIG. 3A) that generally traces the groove 72 may be provided on aninner surface of the handle housing to further decrease the thickness tbetween the grooves 72 and 73 and further facilitate the detachment ofthe plug from the housing.

In the illustrated embodiment of FIGS. 3 and 3A, the plug 68P has afinger 74 that extends inwardly at an angle (e.g., about 90 degrees).The finger 74 may serve multiple functions, including covering therecessed formation 70 in the flange 63 of the receptacle 50 tocompletely cover the port 68 (FIG. 5 ) and/or facilitate detachment ofplug 68P to expose the port (FIG. 6 ).

It is understood that the plug 68P need not necessarily be detachable orremovable from the handle housing half 20. As illustrated in FIG. 5 ,the plug 268P may have a hinge 75 that allows the plug 268P to bepositioned at varying angles (see arrow) relative to the handle housinghalf 20 to expose the port or cover the port.

In use, the housing halves 20 and 22 are joined to form the controlhandle 10. In doing so, a determination is made as to whether thecontrol handle is for assembly with an irrigated catheter or anon-irrigated catheter so that a person assembling the control handlecan decide whether to remove the plug 68P from the housing halve 20 orleave the port 68 and plug 68P intact and the port 68 covered. Althoughthe plug 68P may be removed before the housing halves 20 and 22 arejoined, the plug may also be removed afterwards. The plug may be removedin any suitable manner, including being pried off, punched through orcut, which may be accomplished, manually and/or with an appropriatetool. The grooves 72 and 73 facilitate detachment of the plug from thehousing half 20. Preferably, the plug 69P detaches from the housing half20 along a boundary defined by the grooves 72 and 73. In the embodimentof FIG. 1 , the removal of the plug 68P exposes the port 68, allowing anirrigation side arm 69 to enter the interior cavity 34 of the controlhandle 16. A distal end of the side arm 69 is connected to a luer hub 76in fluid communication with a fluid source (not shown) which providesfluid, e.g., saline, travelling through an irrigation tubing extendingthrough the control handle and the distal portion of the catheter whereit exits the catheter at the tissue treatment site. Alternatively, wherethe port and plug remain intact, the control handle presents anaesthetically pleasing appearance of a finished and undamaged product.

The preceding description has been presented with reference to presentlypreferred embodiments of the invention. Workers skilled in the art andtechnology to which this invention pertains will appreciate thatalterations and changes in the described structure may be practicedwithout meaningfully departing from the principal, spirit and scope ofthis invention. For example, the catheter can be adapted such that thethird puller member advances and retracts another component such as aguide wire or a needle. As understood by one of ordinary skill in theart, the drawings are not necessarily to scale. Accordingly, theforegoing description should not be read as pertaining only to theprecise structures described and illustrated in the accompanyingdrawings, but rather should be read consistent with and as support tothe following claims which are to have their fullest and fair scope.

What is claimed is:
 1. A control handle for a surgical tool, comprising:a first housing half comprising a plug including a finger, the firsthousing half including a peripheral boundary that extends around aportion of the plug on an outer surface of the first housing half; asecond housing half affixed to the first housing half such that thefirst housing half and second housing half together define a housinghaving a proximal end, an interior cavity, and a proximal openingdisposed through the proximal end; and a receptacle disposed through theproximal opening and at least partially disposed in the interior cavity,the receptacle including a peripheral flange defining a recessedformation in which the finger is disposed, in which the proximal openingcomprises a first portion that is defined by the first housing half anda second portion that is defined by the second housing half.
 2. Thecontrol handle of claim 1, in which the peripheral boundary comprises afirst groove that surrounds at least a portion of the plug.
 3. Thecontrol handle of claim 2, in which the first groove comprises a firstreduced thickness portion of the first housing half.
 4. The controlhandle of claim 3, in which a second groove surrounds at least anotherportion of the plug on an inner surface of the first housing half suchthat the second groove comprises a second reduced thickness portion ofthe first housing half.
 5. The control handle of claim 1, in which theplug and first housing half are connected by a hinge.
 6. The controlhandle of claim 1, in which the finger extends away from the firsthousing half at an angle of about 90 degrees.
 7. The control handle ofclaim 1, in which the plug covers a port into the interior cavity. 8.The control handle of claim 1, in which the plug is detachable from arest of the first housing half along the peripheral boundary such that,upon detachment of the plug, a port into the interior cavity ispartially defined by the recessed formation.